Reg Affairs Spec

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our Regulatory Affairs global team within PPD® clinical research services deliver regulatory science services, providing regulatory knowledge which accelerates innovation and improves regulatory decision making – and helps our customers deliver life-changing therapies to patients faster.

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

• Supports the preparation of documentation and submissions under guidance.
• Coordinates and manages client deliverables supporting regulatory compliance.
• Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.
• Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
• Assists in business development and pricing of projects for the department.
• Evaluates client needs in relationship to overall project timelines, quality and delivery.
• Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

• Good English language (written and oral) communication skills as well as local language where applicable
• Good attention to detail and quality as well as editorial/proofreading skills
• Good interpersonal skills to work effectively in a team environment
• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Good negotiation skills
• Capable of working independently with direction and exercising independent judgment
• Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables
• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Basic understanding of medical terminology, statistical concepts, and guidelines
• Good analytical, investigative and problem-solving skills
• Capable of interpreting data